NEW YORK, May 4 /PRNewswire/ -- Children with Attention Deficit/Hyperactivity Disorder (ADHD) who took CONCERTA(R) (methylphenidate HCl) CII demonstrated greater improvement in symptoms such as hyperactivity, impulsivity, and attention than they did with Strattera(R) (atomoxetine), according to preliminary results from the first comparative evaluation of the two medications.
More than 1,300 children between the ages of 6 and 12 completed the open- label Formal Observation of Concerta versus Strattera (FOCUS) study of the two ADHD treatments, conducted by over 300 physicians across the country. Researchers shared interim results of the first 651 children to complete the three-week community-based trial today at the 157th Annual Meeting of the American Psychiatric Association. Study findings were also presented earlier this week at the Pediatric Academic Society annual meeting in San Francisco. A final report, including full data from all participants, will be completed soon.
Physicians participating in the study observed notable differences between CONCERTA, a stimulant medication, and Strattera, a non-stimulant, as early as one week after both treatments began, with CONCERTA consistently producing significantly greater improvement in ADHD symptoms each week of the study. “At the conclusion of the study, doctors reported that children taking CONCERTA had fewer or less severe ADHD symptoms than those taking Strattera,” said study author Jason E. Kemner, MPH, Manager, Outcomes Research, McNeil Consumer & Specialty Pharmaceuticals. “Preliminary data also show a trend of growing differences between both treatments over time.”
About the Study
Male and female subjects between the ages of 6 and 12 years old who met DSM-IV criteria for a primary diagnosis of ADHD or any subtype of the disorder participated in the randomized, open-labeled, parallel-design multi-center study.
Newly diagnosed ADHD patients, treatment naïve subjects, and patients who were taking medication for ADHD before enrollment but were not achieving satisfactory management of their symptoms were randomly assigned by their physician to receive CONCERTA (n= 422 completed to date) or Strattera (n=229 completed to date) for a three-week period.
Study medication was taken once each day in accordance with each product’s dosing instructions. CONCERTA therapy was initiated at 18 mg once daily; Strattera at 0.5 mg/kg per day. During the course of the study, investigators were allowed to increase doses to achieve clinically meaningful management of symptoms.
Physician assessments were made at baseline and once a week during the course of the study using established tools such as the Attention- Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) and a Clinical Global Impressions (CGI)-Improvement of Illness score.
CONCERTA Yields Greater Improvement of ADHD Symptoms
CONCERTA consistently produced significantly greater improvement compared with Strattera on the basis of reduced ADHD-RS scores. Similar improvements also were seen with the physician-rated CGI scores. Differences in ADHD-RS scores between treatment groups showed a significantly greater rate of improvement (symptom score improvement per week; p<0.001) in the CONCERTA group.
The types of adverse events in this study were consistent with the known safety profile of both medications.
This is the first study to compare CONCERTA versus Strattera, according to Kemner, who also noted that although the results of this study suggest a favorable response to CONCERTA compared with Strattera, the final results should give a more complete view of how these treatments compare.
The study was sponsored by McNeil Consumer & Specialty Pharmaceuticals, U.S. marketers of CONCERTA.
About CONCERTA
CONCERTA(R) (methylphenidate HCl) CII is a once-daily extended-release formulation of methylphenidate approved to treat ADHD. CONCERTA uses an advanced OROS(R) extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS system, CONCERTA minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.
CONCERTA should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in CONCERTA; glaucoma, Tourette’s syndrome, tics, or family history of Tourette’s syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Abuse of methylphenidate may lead to dependence. CONCERTA should not be taken by children under 6 years of age.
In clinical studies with patients using CONCERTA, the most common side effects were headache, stomach pain, sleeplessness, and decreased appetite. For more information about CONCERTA, including full U.S. prescribing information, please visit http://www.concerta.net/ or call 1-888-440-7903.
CONCERTA(R) and OROS(R) are registered trademarks of Alza Corporation.
Strattera(R) is a registered trademark of Eli Lilly and Company
McNeil Consumer & Specialty Pharmaceuticals
CONTACT: Gary Esterow of McNeil Consumer & Specialty Pharmaceuticals,+1-215-273-8654, gester1@mccus.jnj.com; or Kathryn Mayurnik of Fleishman-Hillard, +1-212-453-2000, mayurnik@fleishman.com, for McNeil Consumer &Specialty Pharmaceuticals
Web site: http://www.concerta.net/